CLASS II Drug recall · Reported 29 Dec 2021 · FDA Enforcement Report
Moxifloxacin, 1 mg/mL in vial, solution recalled by Denver Solutions
Denver Solutions is recalling Moxifloxacin, 1 mg/mL in vial, solution for intracameral injection, 10 vials/carton, distributed nationwide in the US. The recall was initiated on 29 Nov 2021 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0288-2022
- FDA event ID
- 89136
- Recalling firm
- Denver Solutions, Englewood, CO
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 29 Nov 2021
- FDA classified
- 17 Dec 2021
- Reported
- 29 Dec 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Packaging Defects
- Drug class
- Injectable & IV Drugs
Timeline
| 29 Nov 2021 | Recall initiated by company | |
| 17 Dec 2021 | Classified by FDA | +18 days |
| 29 Dec 2021 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling: Label Mix-up: Vials labeled as moxifloxacin 1 mg/mL may actually contain moxifloxacin 5 mg/mL
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Moxifloxacin, 1 mg/mL, 1mL in 2mL vial, solution for intracameral injection, 10 vials/carton, Rx only, Leiters 13796 Compark Blvd, Englewood, CO 80112, (800) 292-6772, NDC 71449-096-42
Where it was distributed
Nationwide within the United States
Questions about this recall
Why was it recalled?
Labeling: Label Mix-up: Vials labeled as moxifloxacin 1 mg/mL may actually contain moxifloxacin 5 mg/mL
Which lots are affected?
Lot #: 2130958; Expiration Date 03/31/2022
Where was it sold?
Nationwide within the United States
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Denver Solutions
All 22| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | PHENYLephrine HCl in 0.9% Sodium Chloride, 0.5 mg recalled | Denver Solutions | Sterility | Nationwide |
| Drug | CLASS II | Ketamine HCl 50mg per (10 mg per mL) Single Dose Syringe recalled | Denver Solutions | Sterility | Nationwide |
| Drug | CLASS II | Glycopyrrolate, 1mg per, (0.2 mg/mL), Single Dose syringe recalled | Denver Solutions | Sterility | Nationwide |
| Drug | CLASS II | dexmedeTOMIDine HCl PF, in 0.9% Sodium Chloride, 20 mcg recalled | Denver Solutions | Sterility | Nationwide |
| Drug | CLASS II | Rocuronium Bromide 50 mg per (10mg per mL) Single Dose Syringe recalled | Denver Solutions | Sterility | Nationwide |
Other Moxifloxacin recalls
All 21| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Moxifloxacin 0.8 mg/ Preservative-Free Single-Use vials recalled | Imprimis Njof | Sterility | Nationwide |
| Drug | CLASS II | Moxifloxacin 4 mg/ Preservative-Free Single-Use vials recalled | Imprimis Njof | Sterility | Nationwide |
| Drug | CLASS II | Moxifloxacin 5mg/ml in a Single- Dose Vial recalled by Denver Solutions | Denver Solutions | Particulate Matter | Nationwide |
| Drug | CLASS II | Moxifloxacin in Balanced Salt Solution, Solution recalled | Pine Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | Moxifloxacin in Balanced Salt Solution 400 mcg/ (100 mcg/ syringes recalled | Pine Pharmaceuticals | Sterility | Nationwide |